I.T.S. GmbH: Medical Device Recall in 2019 - (Recall #: Z-1718-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After this, the implant has no more use and can be removed.

Product Classification:

Class II

Date Initiated: May 9, 2019

Date Posted: June 12, 2019

Recall Number: Z-1718-2019

Event ID: 82796

Reason for Recall:

The titanium implant has the wrong article number laser marked on it.

Status: Ongoing

Product Quantity: 65 devices

Code Information:

Model Number: 21206-10; Lot Code: 26/F42778

Distribution Pattern:

Worldwide distribution - US nationwide distribution in the states of Florida and Puerto Rico, and countries of Austria, Netherlands, Slovenia, South Africa, Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated